Manager, Clinical Data Management – Study Lead

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $114.8k - $187.4k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Regeneron

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1988

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

💰 Post-IPO Equity on 2023-10

Healthcare • Manufacturing • Biotechnology

Regeneron is a biotechnology company dedicated to turning scientific discoveries into life-changing medicines. The company focuses on a range of serious diseases including allergic, cardiovascular, and metabolic diseases, neuroscience, oncology, hematology, ophthalmology, and rare diseases. It achieves this by integrating biology and technology to develop cutting-edge biologics and genetic medicines. Regeneron is committed to health equity, environmental sustainability, and supporting future STEM talent through initiatives like the Regeneron Science Talent Search. By maintaining high ethical standards and corporate responsibility, Regeneron aims to push the boundaries of science for better healthcare solutions.

📋 Description

• Provide oversight of lead Data Managers on assigned clinical data management studies • Assure planning and execution of data management deliverables according to Regeneron standards and timelines • Assist in developing SOPs, Working Practice, Data Management Plans, and other data management standards • Serve as DM study lead and primary contact for clinical study teams and external partners for one or more complex studies • Provide data management expertise and hands-on support related to eCRF and database design, data quality, and database/data quality status reporting • Oversee data quality review and data acceptance procedures before data analyses and/or database lock • Manage data transfers with CROs and third-party data sources, SAE/AE reconciliation, and MedDRA/WHO-DD coding • Support transfer, locking, and archiving of study databases • Manage scheduling and time constraints across multiple projects • Prepare recommendations for improved data management and data flow processes • Perform and document oversight of CRO data management activities • Ensure electronic case report forms, clinical trial databases, and electronic edit checks are designed, implemented, and maintained according to SOPs and WIs • Identify data quality, CRO performance, documentation, and process execution gaps and ensure resolution • Document sponsor oversight from protocol review through study close-out • Escalate issues and follow them through to resolution • Lead and oversee data management deliverables for assigned studies • Monitor data quality, remediation progress, risks, mitigations, and operational or vendor issues

🎯 Requirements

• Bachelor Degree or equivalent experience in Mathematics, Science or a related field • At least 7 or more years of clinical data management experience in biotechnology, pharmaceutical or health related industry • Perform quality review and inspection readiness tasks to meet quarterly Inspection Readiness Review (IRR) compliance • Follow through on gaps until resolution, escalating as necessary • Experience overseeing data management deliverables for assigned studies • Ability to develop deliverable timelines according to business need and program objectives • Ability to develop snapshot/lock plans and collaborate with the CST for review and approval • Ability to provide regular status updates with metrics to CST • Ability to provide program-level input to and monitor deliverable timelines • Ability to monitor data quality and assess progress of data issue remediation • Ability to identify risks, propose mitigations, and proactively escalate operational, DM vendor, or DM CRO issues • Ability to travel as required, up to 25%

🏖️ Benefits

• Annual bonuses or other incentive plans • Equity awards • Pension or retirement benefits • 401(k) company match • Health and wellness programs • Fitness centers • Medical, dental, vision, life and disability insurance benefits • Paid time off • Family support benefits • Reasonable accommodation during the recruitment process where required